Breaking Through FDA ’s New “Accelerated” Pathway

Discussion and Collaboration The BDP is consistent in vision to the EAP program but has been modified based upon the applicable provisions of the Cures Act. Devices granted designation under the EAP program have been automatically incorporated in the BDP. FDA is currently addressing public comments on a draft guidance that was proposed last year[1]. Regardless, the provisions of the BDP are already effective per the Cures Act. Unlike the EAP, which only allowed IDE, PMA and De Novo applications, the BDP also applies to Q-submissions (Q-Sub), Investigational Device Exemptions (IDE) and 510(k) premarket notifications. Furthermore, combination products under the device pathway are also eligible for BDP. FDA cautions however that combination products may raise unique scientific and regulatory challenges. As a result, it may not be possible to apply all the policies of the BDP to combination products that receive Breakthrough designation. Challenges associated with coordinating review with a different Center must also be considered. Both the EAP and BDP offer manufacturers the opportunity for interactive review with involvement from senior management. One new feature of the BDP is “sprint” discussions. Sprint discussions are offered with the goal of reaching agreement on a specific topic within a time-period proposed by the sponsor and agreed by FDA. The number and format of sprint discussions may vary based on project needs. Unlike with Q-Subs, the information and proposals t...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Source Type: news